Ignite Creation Date:
2024-05-06 @ 7:08 PM
Last Modification Date:
2024-10-26 @ 3:01 PM
Study NCT ID:
NCT05904756
Status:
RECRUITING
Last Update Posted:
2023-10-23
First Post:
2023-06-06
Brief Title:
Patient Satisfaction and Oral Healthy Related Quality of Life of Polyetherketoneketone and Metal Framework
Sponsor:
Mansoura University
Organization:
Mansoura University
Study Overview
Official Title:
Patient Satisfaction and Oral Healthy Related Quality of Life of Polyetherketoneketone and Metal Framework for All-on-four Implant Supported Fixed Detachable Prosthesis A Crossover Study
Status:
RECRUITING
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The patients satisfaction and oral health related quality of life OHRQL of different framework material remains uncertain Thus the aim of this clinical cross over study was to compare patient satisfaction and OHRQL OF polyetherketoneketone and metal framework for All-on-four implant supported fixed prosthesis
Detailed Description:
10 completely edentulous patients around age of 50-60 years will be selected for this study from the Outpatient Clinic Faculty of Dentistry Mansoura University
All selected participants will receive a new complete dentures CD fabricated with bilateral balanced occlusion utilizing semi-anatomical acrylic teeth The patients were instructed to wear the dentures for 3 months to develop adequate neuromuscular control and then clinical performance and patient satisfaction will be evaluated
Each participant will receive 4 implants according to the All-on-4 concept and the implants will be immediately loaded with mandibular denture Three months after osseointegration patients received a definitive fixed detachable prosthesis either from PEKK or metal with composite teeth in a crossover designs Two sets of patients will be made 10 patientsset using random-generated numbers created by a computer program Excel sheet The first 10 participants will recieve metal framework first After 3 months patient satisfaction and OHRQoL will be measured and metal framework will be replaced by PEKK framework After another 3 months measurements will be repeated The second 10 patients received PEKK first and after 3 months measurements will be made Then PEKK framework was replaced by Metal framework and measurements were repeated after another 3 months
All selected participants will receive a new complete dentures CD fabricated with bilateral balanced occlusion utilizing semi-anatomical acrylic teeth The patients were instructed to wear the dentures for 3 months to develop adequate neuromuscular control and then clinical performance and patient satisfaction will be evaluated
Each participant will receive 4 implants according to the All-on-4 concept and the implants will be immediately loaded with mandibular denture Three months after osseointegration patients received a definitive fixed detachable prosthesis either from PEKK or metal with composite teeth in a crossover designs Two sets of patients will be made 10 patientsset using random-generated numbers created by a computer program Excel sheet The first 10 participants will recieve metal framework first After 3 months patient satisfaction and OHRQoL will be measured and metal framework will be replaced by PEKK framework After another 3 months measurements will be repeated The second 10 patients received PEKK first and after 3 months measurements will be made Then PEKK framework was replaced by Metal framework and measurements were repeated after another 3 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None